Systems, methods, and devices for closing holes in body lumens

ABSTRACT

A closure device for closing an opening in tissue is provided. The closure device includes an elongate member through which needles may be deployed. The closure device also includes a foot portion having one or more feet slidably mounted relative thereto. The feet are movable between a deployed position and a delivery position. The feet include cuffs removably mounted therein, with sutures connected between the cuffs. When the feet are in the deployed position and the needles are advanced, the needles securely engage the cuffs and draw the cuffs and suture through the lumen wall so that the opening in the lumen wall can be closed with the sutures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/485,388, filed May 31, 2012, entitled “SYSTEMS, METHODS, AND DEVICESFOR CLOSING HOLES” IN BODY LUMENS, the entire contents of which areincorporated by reference herein.

BACKGROUND 1. Technical Field

The present disclosure relates generally to techniques and devices forclosing openings in body lumens. More particularly, the presentdisclosure relates to systems, devices, and methods for percutaneousclosure of arterial and venous puncture sites, which are usuallyaccessed through a tissue tract.

2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established usingthe well-known Seldinger technique. Vascular access is generallyprovided through an introducer sheath, which is positioned to extendfrom outside the patient's body into the vascular lumen. When vascularaccess is no longer required, the introducer sheath is removed andbleeding at the puncture site stopped.

One common approach for providing hemostasis (the cessation of bleeding)is to apply external force near and upstream from the puncture site,typically by manual compression. This approach suffers from a number ofdisadvantages. For example, the manual compression procedure is timeconsuming, frequently requiring one-half hour or more of compressionbefore hemostasis is achieved. Additionally, such compression techniquesrely on clot formation, which can be delayed until anticoagulants usedin vascular therapy procedures (such as for heart attacks, stentdeployment, non-optical PTCA results, and the like) wear off. Theanticoagulants may take two to four hours to wear off, therebyincreasing the time required before completion of the manual compressionprocedure.

Further, the manual compression procedure is uncomfortable for thepatient and frequently requires analgesics to be tolerable. Moreover,the application of excessive pressure can at times totally occlude theunderlying blood vessel, resulting in ischemia and/or thrombosis.Following manual compression, the patient typically remains recumbentfrom four to as much as twelve hours or more under close observation toassure continued hemostasis. During this time, renewed bleeding mayoccur, resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusions and/or surgicalintervention.

The incidence of complications from the manual compression procedureincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. The compression technique forarterial closure can be risky, and is expensive and onerous to thepatient. Although using highly trained individuals can reduce the riskof complications, dedicating such personnel to this task is bothexpensive and inefficient. Nonetheless, as the number and efficacy oftranslumenally performed diagnostic and interventional vascularprocedures increases, the number of patients requiring effectivehemostasis for a vascular puncture continues to increase.

To overcome the problems associated with manual compression, the use ofbioabsorbable sealing bodies is one example approach that has beenproposed. Generally, this example approach relies on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of drawbacks. Forexample, bioabsorbable sealing bodies may lack a solid mechanicalattachment of the sealing body to the tissue. Due to the lack of a solidmechanical attachment, the sealing body can wander within the tissuetract or move out of the puncture site, thus causing late bleeds.Conversely, if the sealing body wanders and intrudes too far into thearterial lumen, due to the lack of a solid mechanical attachment,intravascular clots and/or collagen pieces with thrombus attached canform and embolize downstream, causing vascular occlusion.

In addition to not having a solid mechanical attachment to the tissue,the sealing bodies may rely upon expandable materials to achievehemostasis. Again, the expandable materials lack the security of a hardmechanical closure, thus potentially causing late bleeds and prolonginghemostasis.

For these reasons, it would be desirable to provide improved devices andmethods to seal body lumen puncture sites. It would be particularlydesirable to provide percutaneous devices and methods for suturing thepuncture sites required for percutaneous vascular procedures.

BRIEF SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. Embodiments of the present invention provide systems, methods,and devices for closing an opening in tissue. Embodiments of theinvention can be configured to close an opening within a body lumen.

For instance, in one exemplary embodiment, a device for closing anopening in tissue includes an elongate member, a plurality of needles, afoot housing, and a foot. The elongate member has a plurality of needlelumens extending from the proximal end toward the distal end. Theneedles are disposed within and are advancable from the plurality ofneedle lumens. The foot housing is disposed at the distal end of theelongate member and defines a first opening and a second openingtherein. The foot is slidably mounted within the foot housing andthrough the first opening between a delivery position and a deployedposition. The foot includes at least two cuffs removably mounted in afirst end and at least two cuffs removably mounted in a second, opposingend. A length of suture is connected between each cuff in the first endof the foot and each cuff in the second end of the foot. The cuffs inthe first end of the foot are positioned below and accessible throughthe second opening in the foot housing and the cuffs in the second endof the foot are positioned outside the foot housing when the foot is inthe deployed position. In contrast, the cuffs in the first end of thefoot are substantially inaccessible through the second opening in thefoot housing when the foot is in the delivery position.

According to another implementation of the present invention, a devicefor closing an opening in a body lumen includes an elongate member and aplurality of needles as mentioned. In addition, the device includes afoot portion disposed at the distal end of the elongate member and aplurality of feet slidably mounted on the foot portion. Each foot of theplurality of feet is slidable between a delivery position and a deployedposition. The plurality of feet move both proximally along the length ofthe foot portion and radially away from the central axis of the footportion when moving from the delivery position to the deployed position.Also, each foot of the plurality of feet has a cuff removably mountedtherein. A length of suture is connected between each pair of cuffs. Thedevice also includes a track and track guide system to facilitatemovement of the feet between the delivery and deployed positions.

In still another exemplary embodiment, a needle includes a shaft havinga proximal end, a distal end, and a longitudinal axis, and a pluralityof needle tips extending from the distal end of the shaft. The pluralityof needle tips can be generally aligned with and parallel to oneanother. Alternatively, the plurality of needle tips can be generallyparallel to and offset from one another.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is an elevation view of a closure device in accordance with oneexemplary embodiment of the present invention;

FIG. 2 is another elevation view of the closure device of FIG. 1,showing a foot in a deployed position;

FIG. 3 is a close-up view of a distal end of the closure device of FIG.1, showing the foot in the deployed position;

FIG. 3A is a cross-sectional view of the distal end of the closuredevice of FIG. 1, with the foot in the delivery position;

FIG. 3B is a cross-sectional view of the distal end of the closuredevice of FIG. 1, with the foot in the deployed position;

FIG. 4A is a top view of one exemplary foot for use in connection withthe closure device of FIG. 1;

FIG. 4B is a top view of another exemplary foot for use in connectionwith the closure device of FIG. 1;

FIG. 4C is a top view of another exemplary foot for use in connectionwith the closure device of FIG. 1;

FIG. 4D is a top view of another exemplary foot for use in connectionwith the closure device of FIG. 1;

FIG. 4E is a top view of another exemplary foot for use in connectionwith the closure device of FIG. 1;

FIG. 5A is a top view of the front side of the distal end of the closuredevice of FIG. 1, showing needles being deployed toward a first end ofthe foot;

FIG. 5B is an elevation view of the back side of the distal end of theclosure device of FIG. 1, showing needles being deployed toward a secondend of the foot;

FIG. 6 is an elevation view of an exemplary needle for use in connectionwith a closure device similar to the closure device of FIG. 1;

FIG. 6A is a close-up view of a distal end of the needle of FIG. 6;

FIG. 7A is a top view of the front side of the distal end of a closuredevice similar to the closure device of FIG. 1, showing a needle fromFIG. 6A being deployed toward a first end of the foot;

FIG. 7B is an elevation view of the back side of the distal end of aclosure device similar to the closure device of FIG. 1, showing a needlefrom FIG. 6A being deployed toward a second end of the foot;

FIG. 8 is a close-up, side view of the distal end of the closure deviceof FIG. 1 inserted into a vessel through a puncture site;

FIG. 9 is a view similar to FIG. 8, except that the foot of the distalend has been deployed or expanded within the vessel;

FIG. 10 is a view similar to FIG. 9, except that needles have beendeployed through the vessel wall and into cuffs mounted on the foot;

FIG. 11 is a view similar to FIG. 10, except that the needles have beendrawn proximally, thereby drawing the cuffs and attached sutures throughthe vessel wall;

FIG. 12 illustrates the needles completely withdrawn into the elongatemember and the foot withdrawn back into the delivery position prior toremoval of the distal end from the vessel;

FIG. 13 illustrates the distal end of the device removed from the vesselafter the sutures have been drawn through the vessel wall;

FIG. 14 illustrates a plunger and the needles withdrawn from the device;

FIG. 15 illustrates a needle housing detached from the plunger and, inphantom, separated into two halves;

FIG. 16 illustrates the sutures, needles, and needle housing halvesfreed from the closure device;

FIG. 17 illustrates a cross-sectional view of the vessel wall showingthe suture tied to close the opening in the vessel wall;

FIGS. 17A-17C illustrate various suture patterns used to close anopening in a vessel wall;

FIG. 18 is an elevation view of a closure device in accordance withanother exemplary embodiment of the present invention;

FIG. 19 is another elevation view of the closure device of FIG. 14,showing foot lobes in deployed position;

FIG. 20A is a cross-sectional view of the distal end of the closuredevice of FIG. 18 taken along cutting plane 20A-20A of FIG. 18, showingcuffs mounted within the foot lobes;

FIG. 20B is a partial cutaway view of the distal end of the closuredevice of FIG. 18, showing a foot lobe in a delivery position and, inphantom view, in a deployed position;

FIG. 21 is a close-up view of the distal end of the closure device ofFIG. 18 inserted into a vessel through a puncture site;

FIG. 22 is a view similar to FIG. 21, except that the foot lobes of thedistal end have been deployed within the vessel;

FIG. 23 is a view similar to FIG. 22, except that needles have beendeployed partially through the vessel wall toward the cuffs mounted inthe foot lobes;

FIG. 24 is a view similar to FIG. 23, except that the needles have beendrawn proximally after engaging the cuffs, thereby drawing the cuffs andattached sutures through the vessel wall; and

FIG. 25 illustrates the needles completely withdrawn into the elongatemember and the foot lobes withdrawn back into the delivery positionprior to removal of the distal end from the vessel.

DETAILED DESCRIPTION

As used herein, the term “distal” is generally defined as in thedirection of the patient or away from a user of a device. In the contextof a medical device intervention with or through a vessel wall, “distal”herein refers to the interior or the lumen side of the vessel wall.Conversely, “proximal” generally means away from the patient or towardthe user. In the context of a medical device intervention with orthrough a vessel wall, “proximal” herein refers to the exterior or outerside of the vessel wall.

The term “suturing” is herein intended to include the process of joiningtwo surfaces or edges together with a fastener or so as to close anaperture, opening, or wound, or join tissues. The fastener is usually asuture such as a thread of material (either polymeric or natural), gut,wire, or the like. The term fastener as used herein also includesclamps, studs, hasps, catches, hooks, rivets, staples, snaps, stitches,VELCROC, buttons, and other coupling members.

Referring to the Figures, suture applying devices that are suitable forsuturing and sealing of percutaneous vascular puncture sites, such asthose made to the femoral artery in a patient's groin, will bedescribed. It will be appreciated, however, that the devices of thepresent invention can be readily adapted for use with punctures made toother hollow body organs and lumens, although it may be necessary tomodify the dimensions and other particular aspects of the devices toaccommodate the different usage environments.

FIGS. 1 and 2 illustrate one example embodiment of a closure device 100.Closure device 100 includes a proximal end 102 and a distal end 104. Asshown in FIGS. 1 and 2, closure device 100 includes an elongate member106 that has a proximal end 108 and a distal end 110. As discussed ingreater detail below, elongate member 106 is generally tubular andincludes one or more lumens that extend generally from proximal end 108to distal end 110. The one or more lumens may be used to facilitate thedelivery of device 100 over a guidewire or to deliver one or moreneedles into a patient. In one embodiment, elongate member 106 is formedof a rigid material such as a stainless steel or other biocompatiblematerial that is rigid. Alternatively, elongate member 106 may be formedof a flexible material such as those materials utilized to form cathetershafts, introducer sheaths, or other medical devices. Suitable materialsinclude polyvinyl chloride (PVC), peak, PTFE, nylon, or any othersimilar materials.

Connected to proximal end 108 of elongate member 106 is an actuatormechanism 112. Actuator mechanism 112 includes a handle 114 tofacilitate manipulation of device 100. Actuator mechanism 112 alsoincludes a plunger 116 used to deploy and retract needles from elongatemember 106, and a lever 118 used to selectively deploy and retract afoot, as discussed in greater detail below.

As shown in FIGS. 1 and 2, distal end 104 of device 100 includes a footportion 120 attached to or extending from distal end 110 of elongatemember 106. In the illustrated embodiment, foot portion 120 is in theform of a foot housing. Elongate member 106 and foot portion 120 may bediscrete pieces that are coupled together, or elongate member 106 andfoot portion 120 may be integrally formed as a single piece.

A foot 122 is movably disposed within foot portion 120. Foot 122 movesbetween a delivery position, in which foot 122 is positionedsubstantially or entirely within foot portion 120 (as illustrated inFIG. 1), and a deployed position, in which foot 122 extends at leastpartially out of foot portion 120 (as illustrated in FIG. 2). When foot122 is in the delivery configuration, distal end 104 can be insertedthrough a puncture site and into a body lumen of a patient. Once distalend 104 is positioned within the body lumen, foot 122 may be moved tothe deployed position. When in the deployed position, foot 122 increasesthe profile of distal end 104, which prevents distal end 104 from beinginadvertently pulled out of the body lumen through the puncture site.Additionally, foot 122 may also be used as a locator to assist aphysician in properly positioning distal end 104 within the body lumen.As will be discussed in greater detail below, foot 122 is operativelyconnected to lever 118 such that foot 122 may be selectively movedbetween the delivery position and the deployed position by actuatinglever 118.

FIGS. 1 and 2 further illustrate that device 100 optionally includes aflexible guidebody 124 extending distally from the distal end of footportion 120. As explained in greater detail below, guidebody 124 can beadvanced along a guidewire into a body lumen. Accordingly, at least thedistal portion of guidebody 124 can be formed from a flexible orelastomeric material that is biocompatible, particularly with blood.

Turning attention to FIG. 3, a close up perspective view of distal end104 is illustrated. As can be seen in FIG. 3, foot 122 includes a firstor distal end 126 and a second or proximal end 128. In the illustratedembodiment, each of first and second ends 126, 128 includes two cuffreceptacles 130. A cuff 132 (with an associated end of a suture 134) isreleasably disposed within each cuff receptacle 130. Each suture 134 isconnected between cuffs 132 disposed in opposing ends of foot 122. Asurface of each cuff receptacle 130 may taper or be funnel shaped so asto guide advancing needles into engagement with cuffs 132 when foot 122is in the deployed position.

As shown in the cross-sectional view of FIG. 3A, foot 122 is in thedelivery position such that foot 122 is positioned substantiallyentirely within foot portion 120. In contrast, FIGS. 3 and 3B illustratefoot 122 in the deployed position. That is, in the deployed position,second end 128 of foot 122 extends outside of foot portion 120 whilefirst end 126 remains positioned within foot portion 120. Foot portion120 includes an opening or window 136 to enable second end 128 to movein and out of foot portion 120 between the delivery and deployedpositions.

As can be seen in FIGS. 3 and 3B, the cuff receptacles 130 and cuffs 132in second end 128 are generally aligned with one or more needle lumens140 in elongate member 106 when foot 122 is in the deployed position. Asnoted above, one or more needles 142 may be passed through or extendedfrom needle lumens 140. Aligning cuff receptacles 130 and cuffs 132 withneedle lumens 140 enables needles 142 to be extended from needle lumens140 toward cuff receptacles 130 so that needles 142 may engage cuffs132, as discussed in greater detail below.

Foot portion 120 also includes a second opening or window 138. Window138 provides access to first end 126 of foot 122. More particularly, thecuff receptacles 130 and cuffs 132 in first end 126 are accessiblethrough window 138 when foot 122 is in the deployed position.Additionally, the cuff receptacles 130 and cuffs 132 in first end 126are generally aligned with one or more needle lumens 140 in elongatemember 106 when foot 122 is in the deployed position. As a result of thecuffs 132 in first end 126 being accessible through window 138 andaligned with needle lumens 140 when foot 122 is deployed, needles 142are extended from needle lumens 140, through window 138, and toward cuffreceptacles 130 so that needles 142 may engage cuffs 132, as discussedin greater detail below.

As noted above, foot 122 is movable between a delivery position and adeployed position. In the embodiment illustrated in FIGS. 3-3B, movementof foot 122 to the deployed position is in the direction of arrow A₁,while movement of foot 122 to the delivery position is in the directionof arrow A₂. Foot 122 may be moved between the delivery and deployedconfigurations in a variety of ways. The Figures illustrate oneexemplary manner in which movement of foot 122 may be accomplished.

In the illustrated embodiment, foot 122 is connected to lever 118 (FIGS.1 and 2) via cables 144, 146. More specifically, first end 126 of foot122 is connected to lever 118 via deployment cable 144 and second end128 of foot 122 is connected to lever 118 via retraction cable 146. Whenlever 118 is moved from the position shown in FIG. 1 to the positionshown in FIG. 2, for example, deployment cable 144 may be drawnproximally up through elongate member 106. As deployment cable 144 isdrawn proximally, deployment cable 144 pulls on first end 126 of foot122. Due to the angle between elongate member 106 and foot portion 120,the pulling of first end 126 by deployment cable 144 causes foot 122 tomove in the direction of arrow A₁ and toward the deployed position.

Retraction cable 146 works in a similar manner as deployment cable 144to move foot 122 to the delivery position. More specifically, when lever118 is moved from the position shown in FIG. 2 to the position shown inFIG. 1, retraction cable 146 is drawn proximally up through elongatemember 106. As retraction cable 146 is drawn proximally, retractioncable 146 pulls on second end 128 of foot 122. As best seen in FIG. 3B,when foot 122 is in the deployed position, retraction cable 146 extendsthrough elongate member 106, into foot portion 120, and out window 136to second end 128. Retraction cable 146 bends to extend from elongatemember 106 and out of window 136 toward second end 128. Due to this bendin retraction cable 146, the pulling of second end 128 by retractioncable 146 causes foot 122 to move in the direction of arrow A₂ andtoward the delivery position.

Foot portion 120 and foot 122 may include additional features thatfacilitate smooth movement of foot 122 between the delivery and deployedpositions. By way of example, foot portion 120 and foot 120 may includea track and track guide system to assist foot 122 in moving smoothlybetween the delivery and deployed positions. In the illustratedembodiment, foot portion 120 includes track guides 148 on opposinginterior surfaces thereof, and foot 120 includes tracks 150 on opposingsides thereof. Tracks 150 are able to slide in track guides 148 as foot122 moves. Tracks guides 148 and tracks 150 assist in keeping foot 122aligned and moving smoothly as cables 144, 146 are moved.

Before leaving FIGS. 3-3B, it is worth noting that sutures 134 extendbetween cuffs 132 around the outside of foot portion 120. Morespecifically, each suture 134 extends from a cuff 132 in first end 126of foot 122, out through window 138, and to a cuff 132 in second end 128of foot 122. By extending sutures 134 between cuffs 132 outside of footportion 120, sutures 134 can be readily removed from distal end 104without being caught in foot portion 120. That is, if a suture 134extended from a cuff 132 in first end 126, through foot portion 120, andout of window 136 to a cuff 132 in second end 128, when the ends ofsuture 134 were pulled away from foot 122, suture 134 would be caught infoot portion 120. Accordingly, sutures 134 extend between cuffs 132 inopposing ends of foot 120 and through window 138.

Attention is now directed to FIG. 4A, which illustrates a top view offoot 122 and a puncture site PS (shown in phantom lines). In theillustrated embodiment, foot 122 includes four cuff receptacles 130 a,130 b, 130 c, 130 d, four corresponding cuffs 132 a, 132 b, 132 c, 132d, and two sutures 134 a, 134 b. Suture 134 a is connected between cuffs132 a and 132 c and suture 134 b is connected between cuffs 132 b and132 d. When sutures 134 a, 134 b are used to close a puncture site PS,sutures 134 a, 134 b form two generally parallel suture loops aroundpuncture site PS, as shown in FIG. 17A. It will be understood thatsutures 134 a, 134 b may be arranged to form other suture loop patterns.For instance, suture 134 a could be connected between cuff 132 a and 132d and suture 134 b could be connected between cuff 132 b and 132 c. Insuch a case, sutures 134 a and 134 b would create a generally X-shapedsuture loop pattern when closing puncture site PS.

While foot 122 has been illustrated and described as including four cuffreceptacles and supporting four cuffs and two sutures, it will beappreciated that the present invention may include or utilize greater orfewer cuff receptacles, cuffs, or sutures. Additionally, the cuffreceptacles, cuffs, and sutures may be arranged in various patterns.FIGS. 4B-4E illustrate a few additional embodiments of feet, withdifferent numbers of cuff receptacles, cuffs, and sutures, and arrangedin a variety of ways. Nevertheless, it will be understood that theillustrated embodiments are provided by way of example only, and thatthe present invention may include still other arrangements and numbersof cuff receptacles, cuffs, and sutures.

With attention to FIG. 4B, there is illustrated a foot 122 a that issimilar to foot 122 in many respects. Foot 122 a has a first end 126 aand a second end 128 a. In first end 126 a are three generally alignedcuff receptacles 130 a, 130 b, 130 c that receive and support cuffs 132a, 132 b, 132 c, respectively. Similarly, second end 128 a includesthree generally aligned cuff receptacles 130 d, 130 e, 130 f thatreceive and support cuffs 132 d, 132 e, 132 f, respectively. Sutures 134a, 134 b, 134 c are connected respectively between cuffs 132 a and 132d, cuffs 132 b and 132 e, and cuffs 132 c and 132 f. When sutures 134 a,134 b, 134 c are used to close a puncture site PS, sutures 134 a, 134 b,134 c form three generally parallel suture loops around puncture sitePS, as shown in FIG. 17B.

Sutures 134 a, 134 b, 134 c may also be connected to cuffs 132 a-f so asto form non-parallel suture loop arrangements. By way of example, suture134 a may be connected between cuffs 132 a and 132 f, suture 134 c maybe connected between cuffs 132 c and 132 d, and suture 134 b may beconnected between cuffs 132 b and 132 e. In such a case, sutures 134 a,134 b, 134 c would form a suture loop pattern around puncture site PSlike the pattern shown in FIG. 17C. Other patterns could also beachieved by connecting sutures 134 a, 134 b, 134 c to cuffs 132 a-f inother combinations.

Turning attention to FIG. 4C, there is illustrated a foot 122 b that issimilar to foot 122 a in many respects. Foot 122 b has a first end 126 band a second end 128 b. In first end 126 b are three cuff receptacles130 a, 130 b, 130 c that receive and support cuffs 132 a, 132 b, 132 c,respectively. Similarly, second end 128 a includes three cuffreceptacles 130 d, 130 e, 130 f that receive and support cuffs 132 d,132 e, 132 f, respectively. Unlike the cuff receptacles in feet 122, 122a, cuff receptacles 130 a-f in foot 122 b are not all generally aligned.Rather, cuff receptacles 130 a, 130 c, 130 d, 130 f are arranged in agenerally rectangular pattern, while cuff receptacles 130 b, 130 e areoffset from the other cuff receptacles. More specifically, cuffreceptacles 130 a, 130 c are generally aligned with one another whilecuff receptacle 130 b is offset therefrom closer to first end 126 b.Similarly, cuff receptacles 130 d, 130 f are generally aligned with oneanother while cuff receptacle 130 e is offset therefrom closer to secondend 128 b.

Sutures 134 a, 134 b, 134 c are connected respectively between cuffs 132a and 132 f, cuffs 132 b and 132 e, and cuffs 132 c and 132 d. Whensutures 134 a, 134 b, 134 c are used to close a puncture site PS,sutures 134 a, 134 b, 134 c form a generally star shaped suture patternaround puncture site PS, as shown in FIG. 17C. Sutures 134 a, 134 b, 134c may also be arranged to form other suture patterns, including threegenerally parallel suture loops as shown in FIG. 17B.

FIG. 4D illustrates a foot 122 c that is similar to foot 122 b in manyrespects. The main difference between foot 122 b and foot 122 c is thatcuff receptacles 130 a-f in foot 122 c are arranged in a generallycircular pattern. Arranging cuff receptacles 130 a-f in a generallycircular pattern enables sutures 134 a-c to extend across puncture sitePS in a number of directions and in a more evenly spaced manner. As withthe previous embodiments, sutures 134 a-c may be connected between cuffs132 a-f in various combinations or patterns to provide a desired suturepattern for closing puncture site PS.

FIG. 4E illustrates a foot 122 d according to yet another exemplaryembodiment of the present invention. As can be seen, foot 122 d includessix cuff receptacles 130 a-f, and supports six cuffs 132 a-f and threesutures 134 a-c. In this embodiment, cuff receptacles 130 a-f and cuffs132 a-f are all substantially aligned with one another, with sutures 134a-c connected between cuffs 132 a-f.

As mentioned above, closure device 100 also includes one or more needles142 that can be deployed from one or more lumens (such as needle lumens140) in elongate body 106 and into a patient. The one or more needles142 can be advanced through needle lumens 140 and into the patient usingplunger 116. More specifically, plunger 116 may be linked to or operablyassociated with the one or more needles 142 such that the one or moreneedles 142 advance out of needle lumens 140 and into the patient asplunger 116 is moved distally (i.e., towards distal end 104). Likewise,plunger 116 may be adapted to withdraw the one or more needles 142 outof the patient and back into needle lumens 140 when plunger 116 is movedproximally (i.e., away from distal end 104).

Attention is now directed to FIGS. 5A and 5B, in which FIG. 5A is a topview of the front of distal end 104, and FIG. 5B is an elevation view ofthe back side of distal end 104. When foot 122 is in the deployedposition within a vessel, needles 142 are deployed from elongate member106 into the patient. As needles 142 penetrate a lumen wall, each needle142 engages and connects to a cuff 132. Once needles 142 are connectedto cuffs 132, the needles and connected cuffs are withdrawn out of thepatient. Drawing cuffs 132 out of the patient pulls sutures 134 throughthe lumen wall so that sutures 134 may be tied to close a puncture inthe lumen wall.

FIGS. 5A and 5B depict four needles 142 being deployed or extended outof elongate member 106 toward cuffs 132. In particular, on the frontside of distal end 104 needles 142 a, 142 b extend from needle lumens140 a, 140 b, respectively, toward cuffs 132 a, 132 b, respectively.Similarly, on the back side of distal end 104 needles 142 c, 142 dextend from needle lumens 140 c, 140 d, respectively, toward cuffs 132c, 132 d, respectively. As needles 142 a-d advance, needle tips 152 a-dengage and connect to cuffs 132 a-d, respectively. Needle tips 152 a-dand cuffs 132 a-d may include complementary features that allow for asecure connection therebetween. Alternatively, needle tips 152 a-d andcuffs 132 a-d may connect to one another via a friction-fit, or othermeans.

Similar to and in connection with the discussion of FIGS. 4A-4E, it willbe appreciated that device 100 may include different numbers of needlelumens 140 and needles 142. For instance, if foot 122 supports fourcuffs, like in FIG. 4A, then device 100 may be designed with four needlelumens and four needles, as shown in FIGS. 5A and 5B. Alternatively, iffoot 122 supports six cuffs as shown in FIGS. 4B-4E, device 100 mayinclude six needle lumens and six needles. Thus, device 100 may have acorresponding number of cuffs, needles, and needle lumens.

Although device 100 may have a corresponding number of cuffs, needles,and needle lumens as discussed above, device 100 may also includenon-corresponding numbers of cuffs, needles, and needle lumens. Forinstance, device 100 may include one or more needles that are configuredto retrieve or withdraw through a lumen wall more than one cuff asdescribed herein.

For instance, FIGS. 6 and 6A illustrate a needle 154 that may be used tosimultaneously retrieve multiple cuffs 132. FIG. 6 illustrates anelevation view of needle 154 while FIG. 6A illustrates a close upperspective view of the distal end of needle 154. As depicted in theFigures, needle 154 includes a shaft 156 and three needle tips 158 a,158 b, 158 c extending from the distal end of shaft 156. Shaft 156 has agenerally rectangular cross-sectional shape and needle tips 158 a, 158b, 158 c are generally aligned with one another.

Each needle tip 158 a, 158 b, 158 c is configured to engage and connectto a cuff 132 supported by foot 122. Needle tips 158 a, 158 b, 158 c andcuffs 132 may include complementary features that allow for a secureconnection therebetween. As depicted in FIG. 6A, each needle tip 158 a,158 b, 158 c has a generally square cross-sectional shape that cancreate a friction-based connection with a cuff 132 when needle tips 158a, 158 b, 158 c are received within cuffs 132. Needle tips 158 a, 158 b,158 c may have other cross-sectional shapes, including circular, oval,or other regular or irregular shapes.

Although needle 154 is depicted as being generally flat with threeneedle tips, it will be appreciated that a multi-tip needle according tothe present invention may have other configurations. Accordingly, amulti-tip needle may include a plurality of needle tips, including twoneedle tips or more than three needle tips. Additionally, a multi-tipneedle may have a cross-sectional shape that is different from thegenerally rectangular shape illustrated. For instance, shaft 156 mayhave a circularly, square, oval, or other cross-sectional shape.

In one embodiment, for example, shaft 156 has a generally V-shapedcross-sectional shape. That is, the opposing sides of shaft 156 aregenerally aligned with one another while the center portion of shaft 156is offset from the opposing sides. As a result of this cross-sectionalshape of shaft 156, needle tip 158 b may be offset from needle tips 158a and 158 c. Needle tips 158 a, 158 b, 158 c may also be offset from oneanother when shaft 156 has other cross-sectional shapes.

Using multi-tip needles, such as needle 154, can reduce the number ofneedle lumens required in elongate member 106. For instance, two needles154 (each having three needle tips 158 a, 158 b, 158 c) can be advancedfrom two needle lumens to retrieve six cuffs rather than advancing sixindividual needles through six different needle lumens. Forming elongatemember 106 with fewer needle lumens can simplify the manufacturing ofelongate member 106.

FIGS. 7A and 7B illustrate views similar to those of FIGS. 5A and 5B.More specifically, FIGS. 7A and 7B illustrate front and back views of adistal end 104′ that is similar in many respects to distal end 104. Incontrast to FIGS. 5A and 5B, which illustrate four separate needlesbeing advanced from four separate needle lumens, FIGS. 7A and 7Billustrate two multi-tip needles 154 being advanced from two needlelumens 160 a, 160 b.

In particular, on the front side of distal end 104′, needle 154 aextends from needle lumen 160 a so that needle tips 158 a, 158 b, 158 cfrom needle 154 a extend toward cuffs 132 a, 132 b, 132 c, respectively,as shown in FIG. 7A. Similarly, as shown in FIG. 7B, on the back side ofdistal end 104′, needle 154 b extends from needle lumen 160 b so thatneedle tips 158 a, 158 b, 158 c from needle 154 b extend toward cuffs132 d, 132 e, 132 f, respectively. As needles 154 a, 154 b advance,needle tips 158 a-c from needle 154 a engage and connect to cuffs 132a-c, respectively, and needle tips 158 a-c from needle 154 b engage andconnect to cuffs 132 d-f, respectively. Once the needle tips areconnected to cuffs 132 a-f, needles 154 a, 154 b can be withdrawnproximally to draw cuffs 132 a-f through the lumen wall, thereby pullingthe ends of sutures 134 a-c through the lumen wall. With the ends ofsutures 134 a-c pulled through the lumen wall, distal end 104′ can beremoved from the body lumen and sutures 134 a-c can be tied to close apuncture site in the lumen wall.

With reference now to FIGS. 8-12, one exemplary method of using device100 will be discussed. In light of the foregoing discussion, it will beunderstood that device 100, as used in the following method, may includea plurality of individual needles (e.g., needles 142) delivered throughindividual needle lumens (e.g., 140), or may include one or moremulti-tip needles (e.g., needles 154) delivered through one or moreneedle lumens (e.g., 160). For simplicity, the following exemplarymethod will be described with reference to needles 162 a, 162 b andneedle lumens 164 a, 164 b. Nevertheless, it will be appreciated thatneedles 162 a, 162 b may be representative of two or more individual-tipor multi-tip needles. Likewise, needle lumens 164 a, 164 b may also berepresentative of two or more needle lumens through which individual-tipor multi-tip needles can be advanced.

As shown in FIG. 8, distal end 104 of device 100 is at least partiallyinserted into a patient such that foot portion 120 passes through apuncture site 166 in a lumen wall 168. As with many transluminalprocedures, device 100 may be introduced into the body lumen using aguidewire. Once foot portion 120 is positioned within the body lumen,foot 122 is moved to the deployed position as shown in FIG. 9. Asdiscussed above, foot 122 may be moved to the deployed position byactuating lever 118. Once foot 122 is in the deployed position, device100 may be moved proximally so that foot portion 120 and foot 122 engagethe interior surface of lumen wall 168. In this manner foot portion 120and foot 122 may be used as locators to ensure proper placement ofdistal end 104 within the body lumen.

Once foot 122 has been deployed and positioned within the body lumen asdesired, needles 162 a, 162 b are advanced from needle lumens 164 a, 164b as shown in FIG. 10. As discussed above, needles 162 a, 162 b may beadvanced out of needle lumens 164 a, 164 b by moving plunger 116(FIG. 1) distally. The advancement of needles 162 a, 162 b out of needlelumens 164 a, 164 b causes needles 162 a, 162 b to extend distally andat least partially radially away from elongate member 106. Morespecifically, as shown in FIG. 10, needles 162 a, 162 b extend out ofneedle lumens 164 a, 164 b at an angle relative to elongate member 106so that needles 162 a, 162 b will pass through lumen wall 168 and tocuffs 132 in foot 122 upon advancement of needles 162 a, 162 b out ofneedle lumens 164 a, 164 b.

As needles 162 a, 162 b engage cuffs 132 in foot 122, the needle tips ofneedles 162 a, 162 b (whether single tip or multi-tip needles) securelyengage cuffs 132 to connect cuffs 132 to needles 162 a, 162 b. With theneedle tips securely connected to cuffs 132, needles 162 a, 162 b arewithdrawn out of the patient by moving plunger 116 (FIG. 1) proximally.As needles 162 a, 162 b are withdrawn, cuffs 132 are also withdrawn outof the patient. More specifically, since cuffs 132 are securelyconnected to needles 162 a, 162 b, withdrawal of needles 162 a, 162 balso causes cuffs 132 to be withdrawn. Even more specifically, as shownin FIG. 11, as needles 162 a, 162 b are drawn back through lumen wall168, cuffs 132 are likewise drawn therethrough. As can also be seen inFIG. 11, since suture 134 is connected between cuffs 132, the ends ofsuture 134 are also drawn through lumen wall 168. As a result, theopposing ends of suture 134 extend through lumen wall 168 on opposingsides of puncture site 166 so that suture 134 spans puncture site 166.

Needles 162 a, 162 b may be withdrawn completely back into needle lumens164 a, 164 b along with cuffs 132 as shown in FIG. 12. Foot 122 is thenmoved back to the delivery position as also shown in FIG. 12. Asdiscussed above, foot 122 is moved from the deployed position to thedelivery position by moving lever 118 from the position shown in FIG. 2to the position shown in FIG. 1. Once foot 122 is in the deliveryposition, distal end 104 is removed from the patient, leaving sutures134 spanning puncture site 166 and extending out of lumen wall 168.Sutures 134 may then be secured together to close puncture site 166.

FIGS. 13-16 illustrate an exemplary manner of removing distal end 104and closing puncture site 166. The illustrated embodiment uses two ormore sutures 134 to close puncture site 166. As discussed above, eachsuture 134 may be connected between two separate needles 142 orindividual needle tips (e.g., 158) on separate multi-tip needles (e.g.,154). In the illustrated embodiment, for instance, three sutures 134a-134 c are connected between six needles 142 a-142 f. Specifically, asbest seen in FIG. 16, suture 134 a is connected between needles 142 aand 142 d, suture 134 b is connected between needles 142 b and 142 e,and suture 134 c is connected between needles 142 c and 142 f.

Once needles 142 a-142 f have been deployed and withdrawn to draw theends of sutures 134 a-134 c through lumen wall 168 as discussed above inconnection with FIGS. 8-12, distal end 104 may be removed from thepatient as shown in FIG. 13. Plunger 116 may then be removed fromactuator mechanism 112 as shown in FIG. 14. More specifically, plunger116 may be drawn proximally relative to actuator 112 until plunger 116is removed from the proximal end of actuator mechanism 112.

As can be seen in FIG. 14, a detachable needle housing 159 is disposedon the distal end of plunger 116. Housing 159 may hold the proximal endsof needles 142 such that movement of plunger 116 causes a correspondingmovement of needles 142. Accordingly, removal of plunger 116 fromactuator mechanism 112 may likewise cause needles 142 to be at leastpartially withdrawn proximally from actuator mechanism 112. FIG. 14illustrates needles 142 completely withdrawn from actuator mechanism112.

As shown in FIG. 15, needle housing 159 may be detached from plunger 116to facilitate the removal of closure device 100 from off of sutures 134.After detaching needle housing 159 from plunger 116, needle housing 159may be separated into two halves 159 a, 159 b, as shown in phantom linesin FIG. 15. In the illustrated embodiment, half 159 a holds the proximalends of needles 142 a-142 c and half 159 b holds the proximal ends ofneedles 142 d-142 f.

With needle housing 159 detached from plunger 116 and separated intohalves 159 a, 159 b, halves 159 a, 159 b, with their associated needles142 and attached sutures 134, may be passed through actuator mechanism112 and elongate member 106 so as to free sutures 134, needles 142, andhalves 159 a, 159 b from closure device 100. More specifically, half 159a and its associated needles 142 may be passed distally back throughactuator mechanism 112 and the needle lumen 140 associated with theneedles 142 of half 159 a so that half 159 a and its needles 142 exitthe distal end of needle lumen 140, thereby freeing half 159 a and itsneedles 142 from device 100. Half 159 b and its associated needles 142may similarly be passed back through actuator mechanism 112 and theneedle lumen 140 associated with the needles 142 of half 159 b so thathalf 159 b and its needles 142 exit the distal end of needle lumen 140associated therewith, thereby freeing half 159 b and its needles 142from device 100.

Alternatively, closure device 100 may have one or more slots extendingthe length thereof through which sutures 134 and/or needles 142 may bepassed to remove closure device 100 from off of sutures 134. Forinstance, the slots may open the needle lumens 140 to the externalsurface of device 100 such that sutures 134 and/or needles 142 may bepassed therethrough to remove device 100. In other embodiments, theslots may open the needle lumens 140 to a central internal channelwithin device 100, such that sutures 134 and needles 142 may be passedfrom needle lumens 140 into the central channel so that sutures 134,needles 142, and halves 159 a, 159 b may be passed through the centralchannel and out the distal end of device 100.

In any case, once closure device 100 has been removed from sutures 134,halves 159 a, 159 b enable sutures 134 a-134 c to be arranged in anorderly manner, as shown in FIG. 16, thereby enabling a doctor (or otheruser) to quickly identify opposing ends of each suture 134. The doctor(or other user) may then cut the opposing ends of each suture from theneedles and tie them off individually to close puncture site 166, asshown in FIG. 17. Being able to quickly identify opposing ends of eachsuture 134 allows the user to better manage the sutures and ensure thatpuncture site 166 is properly closed. After the sutures have been cutfrom the needles, the detachable housing may be re-attached to theplunger, or may be disposed.

Depending on the number and arrangement of sutures 134, various closurepatterns and knots may be used to close puncture site 166. FIGS. 17A-17Cillustrate various example manners of closing puncture site 166. Forinstance, FIG. 17A illustrates two sutures tied in a parallelarrangement. FIG. 17B illustrates a similar parallel arrangement withthree sutures. FIG. 17C illustrates three sutures tied in a star shapedarrangement. Sutures 134 can be secured in any suitable manner,including by tying or with clamps, clips, or other closure devices.

Attention is now directed to FIGS. 18-25 which illustrate a closuredevice 200 according another exemplary embodiment of the presentinvention, and a method for using closure device 200. Closure device 200is similar to closure device 100 in many respects. As a result, thefollowing discussion of closure device 200 will focus primarily on thoseaspects of closure device 200 that are different from closure device100.

Closure device 200 includes a proximal end 202 and a distal end 204. Asshown in FIGS. 18 and 19, closure device 200 includes an elongate member206 that has a proximal end 208 and a distal end 210. Elongate member206 is generally tubular and includes one or more lumens that extendgenerally from proximal end 208 to distal end 210. The one or morelumens may be used to facilitate the delivery of device 200 over aguidewire or to deliver one or more needles into a patient. As can be sebeen in FIGS. 18 and 19, elongate member 206 has a generally uniformdiameter along its length.

Connected to proximal end 208 of elongate member 206 is an actuatormechanism 212. Actuator mechanism 212 includes a handle 214 tofacilitate manipulation of device 200. Actuator mechanism 212 alsoincludes a plunger 216 used to deploy and retract needles from elongatemember 206, and a lever 218 used to selectively deploy and retract aplurality of feet.

As shown in FIGS. 18 and 19, distal end 204 of device 200 includes afoot portion 220 attached to or extending from distal end 210 ofelongate member 206. Elongate member 206 and foot portion 220 may bediscrete pieces that are coupled together, or elongate member 206 andfoot portion 220 may be integrally formed as a single piece.

A plurality of feet 222 are movably mounted on foot portion 220. Feet222 are movable between a delivery position and a deployed position. Inthe delivery position, which is illustrated in FIG. 18, feet 222 arepositioned at a first location along the length of device 200 and aresubstantially or entirely within a diameter that is about equal to anouter diameter of elongate member 206. In contrast, when feet 222 are inthe deployed position as illustrated in FIG. 19, feet 222 are positionedat a second, more proximal location along the length of device 200 andextend radially beyond the outer diameter of elongate member 206.

When feet 222 are in the delivery configuration, distal end 204 can beinserted through a puncture site and into a body lumen of a patient.Once distal end 204 is positioned within the body lumen, feet 222 may bemoved to the deployed position. When in the deployed position, feet 222increase the profile of distal end 204, which prevents distal end 204from being inadvertently pulled out of the body lumen through thepuncture site. Additionally, feet 222 may also be used as a locator toassist a physician in properly positioning distal end 204 within thebody lumen. As will be discussed in greater detail below, feet 222 areoperatively connected to lever 218 such that feet 222 may be selectivelymoved between the delivery position and the deployed position byactuating lever 218.

FIGS. 18 and 19 further illustrate that device 200 optionally includes aflexible guidebody 224 extending distally from the distal end of footportion 220. As with guidebody 124, guide body 224 can be advanced alonga guidewire into a body lumen. Accordingly, at least the distal portionof guidebody 224 can be formed from a flexible or elastomeric materialthat is biocompatible, particularly with blood.

Turning attention to FIGS. 20A and 20B, a horizontal cross-sectionalview (taken along cross-sectional lines 20A-20A in FIG. 18) and apartial cutaway view of distal end 204, including foot portion 220 andplurality of feet 222, are illustrated. In the present embodiment,plurality of feet 222 includes four feet, identified as feet 222 a, 222b, 222 c, 222 d, respectively, but may include more or fewer feet. Ascan be seen in FIG. 20A, feet 222 a-d are disposed radially about footportion 220. Extending through the center of foot portion 220 is anactuator lumen 226, which also extends at least partially throughelongate body 206. A rod or cable 228 extends through actuator lumen 226to connect feet 222 a-d to lever 218.

As lever 218 is moved in the direction of arrow A₃, as shown in FIG. 19,rod 228 is drawn proximally through actuator lumen 226. The proximalmovement of rod 228 causes feet 222 a-d to move from the deliveryposition shown in FIG. 18 to the deployed position shown in FIG. 19. Incontrast, as lever 218 is moved in the direction opposite to arrow A₃,rod 228 is moved distally through actuator lumen 226, thereby movingfeet 222 a-d from the deployed position to the delivery position.

FIG. 20B illustrates a cutaway view of distal end 204, showing foot 222a in the delivery and deployed positions. Specifically, FIG. 20B showsfoot 222 a in solid lines in the delivery position and in phantom linesin the deployed position. As can be seen in FIG. 20B, when in thedelivery position, foot 222 a is located more distally along the lengthof distal end 204 than when foot 222 a is in the deployed position. Inother words, as foot 222 a moves from the delivery position to thedeployed position (e.g., generally in the direction of arrow A₄), foot222 a moves proximally along the length of distal end 204.Correspondingly, as foot 222 a moves from the deployed position to thedelivery position (e.g., generally in the direction opposite to arrowA₄), foot 222 a moves distally along the length of distal end 204.

Likewise, when in the delivery position, foot 222 a is located radiallycloser to the center of foot portion 220 (e.g., actuator lumen 226) thanwhen foot 222 a is in the deployed position. In other words, as foot 222a moves from the delivery position to the deployed position, foot 222 amoves radially away from the center of foot portion 220.Correspondingly, as foot 222 a moves from the deployed position to thedelivery position, foot 222 a moves radially closer to the center ofdistal end 204.

To facilitate movement of feet 222 a-d between the delivery and deployedpositions, foot portion 220 and feet 222 a-d include a track system. Thetrack system enables feet 222 a-d to move along the length of device 200while also moving radially relative to foot portion 220. In theillustrated embodiment, foot portion 220 includes track guides 230 a-ddisposed within the outer surface thereof, and feet 222 a-d includetracks 232 a-d, respectively. Tracks 232 a-d are slidably positionedwithin track guides 230 a-d, respectively, so that tracks 232 a-d areable to slide within track guides 230 a-d as feet 222 a-d move betweenthe delivery and deployed positions.

As noted above, FIG. 20B illustrates a partial cutaway view of distalend 204. More specifically, FIG. 20B illustrates a partial cutaway viewof distal end 204 showing foot 222 a in solid lines in the deliveryposition and in phantom lines in the deployed position. FIG. 20B alsoshows that track guide 230 a is angled relative to the length of device200 and/or a central or longitudinal axis A of distal end 204. That is,track guide 230 a has a first or distal end 234 that is positionedradially closer to central axis A than a second or proximal end 236.

The angled nature of track guide 230 a causes foot 222 a to moveradially closer to and further away from axis A as foot 222 a movesalong the length of device 200. For instance, as rod 228 pulls foot 222a in the direction of arrow A₄, the angled nature of track guide 230 acauses foot 222 a to also move in the direction of arrow A₅. Similarly,as rod 228 pushes foot 222 a in the direction opposite of arrow A₄, theangled nature of track guide 230 a causes foot 222 a to also move in thedirection opposite of arrow A₅. As a result, foot 222 a is able to moveboth longitudinally along a portion of the length of device 200 as wellas radially relative to foot portion 220.

Although FIG. 20B only illustrates track guide 230 a and foot 222 a, itwill be understood that track guides 230 b-d and feet 222 b-d can havesimilar or identical configurations. Additionally, track guides 230 a-dand tracks 232 a-d may also have other configurations than thoseillustrated. For instance, track guides may be formed on feet 222 whiletracks are formed on foot portion 220. Furthermore, while track guides230 are illustrated as being generally straight, track guides may alsobe curved so long as they cause feet 222 to move radially as feet 222move longitudinally.

As can be seen in FIG. 20B, foot 222 a does not extend substantiallybeyond the outer diameter of elongate member 206 when foot 222 a is inthe delivery position. As a result, foot 222 a is in a relativelycompact position and is able to be readily inserted through a puncturesite and into a body lumen. In contrast, foot 222 a extends radiallybeyond the outer diameter of elongate member 206 when foot 222 a is inthe deployed position (as shown in phantom lines in FIG. 20B). Device200 can be configured so that feet 222 a-d, when in the deployedposition, extend out radially far enough that feet 222 a-d can engage orbe positioned adjacent to an interior or distal surface of a body lumenwall.

Returning again to FIG. 20A, feet 222 a-d include cuff receptacles 238a-d. Cuffs 240 a-d are releasably disposed within cuff receptacles 238a-d, respectively. Sutures 242, 244 are connected between pairs of cuffs240 a-d. In the illustrated embodiment, suture 242 is connected betweencuffs 240 a, 240 c, while suture 244 is connected between cuffs 240 b,240 d. When sutures 242, 244 are used to close a puncture site, sutures242, 244 will form a generally X-shaped suture loop pattern.Nevertheless, sutures 242, 244 may be connected between cuffs 240 a-d insuch an arrangement so as to form other suture loop patterns. Forinstance, suture 242 could be connected between cuff 240 a and cuff 240d and suture 244 could be connected between cuff 240 b and cuff 240 c.In such a case, sutures 242, 244 would create two generally parallelsuture loops around a puncture site, similar to those shown in FIG. 17A.

As can be seen in FIGS. 19 and 21, feet 222 a-d are generally alignedwith needle lumens 246 a-d in elongate member 206 when feet 222 a-d arein the deployed position. As noted above, needles 248 a-d may be passedthrough or extended from needle lumens 246 a-d. Aligning feet 222 a-dwith needle lumens 246 a-d enables needles 248 a-d to be extended fromneedle lumens 246 a-d toward cuffs 240 a-d so that needles 248 a-d mayengage cuffs 240 a-d.

Needles 248 a-d can be advanced through needle lumens 246 a-d usingplunger 216. More specifically, plunger 216 may be linked to or operablyassociated with needles 248 a-d such that needles 248 a-d advance out ofneedle lumens 246 a-d as plunger 216 is moved distally (i.e., towardsdistal end 204). Likewise, plunger 216 may be adapted to withdrawneedles 248 a-d back into needle lumens 246 a-d when plunger 216 ismoved proximally (i.e., away from distal end 204).

When feet 222 a-d are in the deployed position within a body lumen,needles 248 a-d can be deployed from elongate member 206 into thepatient. As needles 248 a-d penetrate the lumen wall, each needle 222a-d engages and connects to a cuff 240 a-d in a manner similar to thatdescribed above in connection with needles 142 and cuffs 132. Onceneedles 248 a-d are connected to cuffs 240 a-d, needles 248 a-d andconnected cuffs 240 a-d are withdrawn out of the patient. Drawing cuffs240 a-d out of the patient pulls sutures 242, 244 through the lumen wallso that sutures 242, 244 may be tied to close a puncture in the lumenwall.

As with device 100, device 200 may have a corresponding number of cuffs,needles, and needle lumens as discussed above. Also like device 100,device 200 may also include non-corresponding numbers of cuffs, needles,and needle lumens. For instance, device 200 may include one or moreneedles that have multiple needle tips configured to retrieve orwithdraw through a lumen wall more than one cuff as described herein.

With reference to FIGS. 21-25, one exemplary method of using device 200will be discussed. In light of the foregoing discussion, it will beunderstood that device 200, as used in the following method, may includea plurality of individual needles (e.g., needles 248) delivered throughindividual needle lumens (e.g., 246), or may include one or moremulti-tip needles (similar to needles 154) delivered through one or moreneedle lumens (similar to needle lumens 160). For simplicity, thefollowing exemplary method will be described with reference to needles248 and needle lumens 246. Nevertheless, it will be appreciated thatneedles 248 may be representative of two or more individual-tip ormulti-tip needles. Likewise, needle lumens 246 may also berepresentative of two or more needle lumens through which individual-tipor multi-tip needles can be advanced

As shown in FIG. 21, distal end 204 of device 200 is at least partiallyinserted into a patient such that foot portion 220 passes at leastpartially through a puncture 250 in a lumen wall 252. As with manytransluminal procedures, device 200 may be introduced into the bodylumen using a guidewire. Once foot portion 220 is positioned within thebody lumen, feet 222 a-d are moved from the delivery position shown inFIG. 21 to the deployed position shown in FIG. 22. As discussed above,feet 222 a-d may be moved to the deployed position by actuating lever218. Once feet 222 a-d are in the deployed position, device 200 may bemoved proximally so that feet 222 a-d engage the interior surface oflumen wall 252. In this manner, feet 222 a-d may be used as locators toensure proper placement of distal end 204 within the body lumen.

Once feet 222 a-d have been deployed and positioned within the bodylumen as desired, needles 248 a-d are advanced from needle lumens 246a-d as shown in FIG. 23. As discussed above, needles 248 a-d may beadvanced out of needle lumens 246 a-d by moving plunger 216 (FIG. 1)distally. The advancement of needles 248 a-d out of needle lumens 246a-d causes needles 248 a-d to extend distally and at least partiallyradially away from elongate member 206. More specifically, as shown inFIG. 23, needles 248 a-d extend out of needle lumens 246 a-d at an anglerelative to elongate member 206 so that needles 248 a-d pass throughlumen wall 252 and toward cuffs 240 a-d in feet 222 a-d as needles 248a-d advance out of needle lumens 246 a-d.

As needles 248 a-d engage cuffs 240 a-d in feet 222 a-d, the needle tipsof needles 248 a-d (whether single tip or multi-tip needles) securelyengage cuffs 240 a-d to connect cuffs 240 a-d to needles 248 a-d. Withthe needle tips securely connected to cuffs 240 a-d, needles 248 a-d arewithdrawn out of the patient by moving plunger 216 (FIG. 1) proximally.As needles 248 a-d are withdrawn, cuffs 240 a-d are also withdrawn outof the patient. More specifically, since cuffs 240 a-d are securelyconnected to needles 248 a-d, withdrawal of needles 248 a-d also causescuffs 240 a-d to be withdrawn. Even more specifically, as shown in FIG.24, as needles 248 a-d are drawn back through lumen wall 252, cuffs 240a-d are likewise drawn therethrough. As can also be seen in FIG. 24,since sutures 242, 244 are connected between cuffs 240 a-d, the ends ofsuture 242, 244 are also drawn through lumen wall 252. As a result, theopposing ends of each suture 242, 244 extend through lumen wall 252 onopposing sides of puncture site 250 so that each suture 242, 244 spanspuncture site 250.

Needles 248 a-d may be withdrawn completely back into needle lumens 246a-d along with cuffs 240 a-d as shown in FIG. 25. Feet 222 a-d are thenmoved back to the delivery position as also shown in FIG. 25. Asdiscussed above, feet 222 a-d are moved from the deployed position tothe delivery position by moving lever 218 from the position shown inFIG. 19 to the position shown in FIG. 18. Once feet 222 a-d are in thedelivery position, distal end 204 is removed from the patient, leavingsutures 242, 244 spanning puncture site 250 and extending out of lumenwall 252. Sutures 242, 244 are then secured to close puncture 250 asshown in FIGS. 17-17C. Sutures 242, 244 can be secured in any suitablemanner, including by tying or with clamps, clips, or other closuredevices.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope. It shall be furtherunderstood that although the present invention has been described inrelation to vessel closure, it is contemplated that the closurecomponent of the present invention may be utilized to close otheropenings in the body such as PFO openings, or openings formed in organssuch as the stomach for certain surgical procedures.

What is claimed is:
 1. A device for closing an opening in a body lumen,comprising: an elongate member having a plurality of needle lumens; aplurality of needles disposed within and advanceable from the pluralityof needle lumens, a proximal end of the plurality of needles beingmounted to a housing having a first portion and a second portion, thefirst portion and the second portion being separable to separate a firstplurality of needles of the plurality of needles from a second pluralityof needles of the plurality of needles; a foot portion disposed distal adistal end of the plurality of needle lumens, the foot portion having acentral axis; and a plurality of feet slidably mounted on the footportion and slidable both proximally along a length of the foot portionand radially away from the central axis of the foot portion, each footof the plurality of feet having a cuff removably mounted therein.
 2. Thedevice as recited in claim 1, wherein a length of suture connects pairsof cuffs.
 3. The device as recited in claim 1, wherein each foot of theplurality of feet being slidable between a delivery position and adeployed position.
 4. The device as recited in claim 3, wherein eachfoot is slidable proximally along the length of the foot portion andradially away from the central axis of the foot portion when moving fromthe delivery position to the deployed position.
 5. The device as recitedin claim 1, further comprising a track and a track guide thatfacilitates movement of the plurality of feet.
 6. The device as recitedin claim 5, wherein the track guide is angled relative to the centralaxis of the foot portion.
 7. The device as recited in claim 1, whereinthe foot portion comprises an actuator lumen extending at leastpartially therethrough.
 8. The device as recited in claim 1, wherein theplurality of needles comprise at least one needle having a shaft and aplurality of needle tips extending from a distal end of the shaft. 9.The device as recited in claim 1, further comprising a plungeroperatively associated with the plurality of needles, wherein distalmovement of the plunger advances the plurality of needles from theplurality of needle lumens.
 10. A device for closing an opening in abody lumen, comprising: an elongate member having a proximal end, adistal end, a central passage and a plurality of needle lumens extendingfrom the proximal end toward the distal end; a plurality of needlesdisposed within and advanceable from the plurality of needle lumens; afoot portion disposed at the distal end of the elongate member, the footportion having a central axis; a plurality of feet slidably mounted onthe foot portion, each foot of the plurality of feet being slidablebetween a delivery position and a deployed position, the plurality offeet moving both proximally along a length of the foot portion andradially away from the central axis of the foot portion when moving fromthe delivery position to the deployed position, each foot of theplurality of feet having a cuff removably mounted therein, with a lengthof suture being connected between each pair of cuffs; and a track andtrack guide system that facilitates movement of the plurality of feetbetween the delivery and deployed positions, the foot portion includes aplurality of track guides and each foot includes a track.
 11. The deviceas recited in claim 10, wherein the plurality of track guides are angledrelative to the central axis of the foot portion, an angledconfiguration of the track guides facilitating radial movement of theplurality of feet.
 12. The device as recited in claim 10, wherein thefoot portion comprises an actuator lumen extending at least partiallytherethrough.
 13. The device as recited in claim 12, further comprisingan actuator extending through the central passage and the actuatorlumen, the actuator being operatively associated with the plurality offeet such that proximal movement of the actuator causes the plurality offeet to move from the delivery position to the deployed position. 14.The device as recited in claim 10, wherein the plurality of needlescomprise at least one needle having a shaft and a plurality of needletips extending from a distal end of the shaft.
 15. The device as recitedin claim 10, further comprising a plunger operatively associated withthe plurality of needles, wherein distal movement of the plunger causesthe plurality of needles to advance from the plurality of needle lumensand engage the cuffs when the plurality of feet are in the deployedposition.